- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03565874
Heart Rate Variability and Prematurity
Heart Rate Variability Biofeedback (HRVB) With Mothers Who Delivered a Preterm Infant: A Feasibility Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1004
- Centre Hospitaliter Universitaire Vaudois
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Delivery between 33 and 37 weeks of gestational age
- Living in Lausanne or surroundings
- Infant is expected to survive
- Singleton birth
- Consent of mother to participate in the study
- Sufficient French-speaking skills to fill out the questionnaires
- Mothers older than 18 years of age
Exclusion Criteria:
- Infant with cranial abnormality/neurological squeal such as cystic periventricular leukomalacia (PVL) and intraventricular haemorrhage (IVH)
- Maternal history of drug or alcohol abuse or severe psychiatric disorders before or during pregnancy
- Infant with congenital anomalies
- Infant with hearing or vision loss
- Mother and infant participating in another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heart Rate Variability Biofeedback
HRVB program conducted over the course of 2 weeks of individual daily exercises for 20 minutes per day.
|
Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company.
Then, each participant will receive training on the HRVB program using an Emwave device.
The HRVB program itself will be carried individually for 20 min daily over the course of two weeks.
Five daily sessions of 10 minutes will be considered as the minimum adherence to the program.
Each participant will be asked to report in a diary all eventual major stressful life events.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Acceptance (Ratio)
Time Frame: After completing the HRVB program (on average 3 weeks)
|
The ratio of acceptance of study participation (number of participants who accept to participate to the study / number of participants to whom the study has been proposed) * 100
|
After completing the HRVB program (on average 3 weeks)
|
Feasibility: Drop-out
Time Frame: After completing the HRVB program (on average 3 weeks)
|
The ratio of drop out.
|
After completing the HRVB program (on average 3 weeks)
|
Feasibility: Number of Sessions Completed During Study
Time Frame: After completing the HRVB program (on average 3 weeks)
|
Compliance with study protocol regarding the number of sessions attended by the participants.
|
After completing the HRVB program (on average 3 weeks)
|
Satisfaction Regarding the Intervention
Time Frame: After completing the HRVB program (on average 3 weeks)
|
Satisfaction will be measured through a questionnaire. Questions will be asked about global satisfaction, utility, timing and difficulty about their experience (assessed on single item Likert scale). Higher scores reflects more satisfaction. Possible range 2 to 10. |
After completing the HRVB program (on average 3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HRV: RMSDD
Time Frame: Before and after completing the HRVB program (on average 3 weeks).
|
The root-mean square differences of successive R-R intervals (RMSDD) will be used as measures to assess HRV level before and after participation in the HRVB program.
|
Before and after completing the HRVB program (on average 3 weeks).
|
HRV: HF
Time Frame: Before and after completing the HRVB program (on average 3 weeks).
|
High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program.
|
Before and after completing the HRVB program (on average 3 weeks).
|
Stress
Time Frame: Before and after completing the HRVB program (on average 3 weeks).
|
Perceived stress will be measured on the Perceived Stress Scale-14 (PSS-14).
PSS-14 score is calculated on 14 items ranging from 0 to 4. The 7 positive state items (4,5,6,7,9,10 and 13) must have their score reversed (0=4, 1=3, 2=2, 3=1, 4=0) in order to calculate the total score by summing up all 14 items.(Min=0,
Max=56).
Higher scores indicate a higher level of stress.
A validated French version of the PSS will be used.
|
Before and after completing the HRVB program (on average 3 weeks).
|
PTSD
Time Frame: Before and after completing the HRVB program (on average 3 weeks).
|
Post-traumatic stress disorder symptoms will be measured with the Post-traumatic stress disorder checklist (PCL-5) for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5).
PCL-5 is a 20 items self-report measure that assesses the presence and severity of PTSD symptoms.
Items on the PCL-5 correspond to DSM-5 criteria for PTSD.
Each item is rated on a 5 point Likert scale (from "Not at all" to "Extremely").
Total score is calculated by adding up scores for all items (Min = 0, Max = 80).
Higher scores indicate a higher level of PTSD.
A validated French version of the PCL will be used.
|
Before and after completing the HRVB program (on average 3 weeks).
|
Anxiety
Time Frame: Before and after completing the HRVB program (on average 3 weeks).
|
Anxiety symptoms will be measured with the State and Trait Anxiety Inventory (STAI). STAI score is calculated on 40 items (20 items assessing trait anxiety and 20 items assessing state anxiety) rated on a 4 point Likert scale (from "Almost never" to "Almost always"). Total score for state and trait anxiety is calculated by adding up all items (Min = 20, Max = 80). Higher scores indicate a higher level of anxiety. A validated French version of the STAI will be used. |
Before and after completing the HRVB program (on average 3 weeks).
|
Depression
Time Frame: Before and after completing the HRVB program (on average 3 weeks).
|
Depression symptoms will be assessed with a 13-item short form of the Beck Depression Inventory (BDI), which is a 13-item, self-report rating inventory that measures symptoms of depression. The scale for each item goes from 0 to 3. Total score is calculated by adding up scores from each item (Min = 0, Max = 39). Higher scores indicate a higher level of depression. A validated French version of the BDI will be used. |
Before and after completing the HRVB program (on average 3 weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sébastien Urben, PhD, Centre Hospitalier Universitaire Vaudois
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Taichung Veterans General HospitalUnknown
Clinical Trials on Heart rate variability biofeedback
-
University of California, San DiegoUnknown
-
University of Southern CaliforniaNational Institute of Mental Health (NIMH)Recruiting
-
National Defense Medical Center, TaiwanCompletedPsychological Distress | Acute Ischemic Stroke | Biofeedback | Autonomic Dysfunction, Cognitive Function
-
National Defense Medical Center, TaiwanRecruitingChronic Kidney Diseases | Inflammatory Response | Autonomic DysfunctionTaiwan
-
Prisma Health-UpstateUniversity of South CarolinaCompleted
-
Rutgers, The State University of New JerseyWithdrawnASTHMA | ANXIETY
-
Columbia UniversityNational Institute on Aging (NIA)Completed
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawn
-
Western University, CanadaParkwood Hospital, London, OntarioCompletedPost-Concussion SyndromeCanada